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Clinical Trial 21136

Cancer Type: Sarcoma
Study Type: Treatment
NCT#: NCT05301283

Phase: Phase II
Principal Investigator: Naghavi, Arash

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Overview

Study Title

Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma

Summary

The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.

Objective

Primary Objective: Utilizing radiomic habitats to focally dose escalate radioresistant subregions of high-grade soft tissue sarcoma to improve the rate of favorable pathologic response (Favorable pathologic response [FPR]: tumor necrosis >/= 95%) at the time of surgery. Secondary Objectives: To estimate the rates of acute toxicity (defined by CTCAE v5.0 within 120 days) for patients with high-grade soft tissue sarcoma treated with preoperative habitat-directed dose escalation To estimate R0 resection rate To evaluate early treatment response to radiation on imaging To evaluate pathologic response to radiation of each habitat

Treatments

Therapies

Radiotherapy

Medications

Radiotherapy ()

Inclusion Criteria

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.
  • Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
  • Pathologically (histologically or cytologically) proven diagnosis of high-grade Soft Tissue Sarcoma (STS) of the deep trunk and extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage)
  • Primary site deemed resectable prior to the start of trial
  • American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
  • Patients must have clinically or radiographically evident measurable disease at the primary site.
  • Pre-Radiation Therapy (RT) and post-RT MRI within 4 weeks of the start and completion of RT, respectively
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3.
  • Deemed a surgical candidate
  • Participant agrees to blood and plasma preservation for future analysis.
  • Other criteria may apply

  • Exclusion Criteria

    Exclusion Criteria:

  • Contraindications to an MRI
  • Positive urine pregnancy test
  • Gross total excision of primary STS, including an unplanned excision
  • Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
  • Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.
  • Other exclusions may apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.